WASHINGTON, D.C. — Teleflex Inc., a medical device manufacturing company, announced a voluntary recall of its Comfort Flo Humidification System, Reuters said. Teleflex Inc. reported that it received 102 consumer complaints regarding its Comfort Flo Humidification System. Patients experienced water infiltrating the system requiring immediate intervention, without which, the person could have sustained a severe injury or died. The U.S. Food and Drug Administration (FDA) reviewed the recall plan file by Teleflex Inc. and determined that the recall program should be classified as a Class I recall. The FDA issues Class I recalls when the defective medical device threatens to cause a serious injury or death.
Yahoo Finance reported that the company’s Class I recall program concerned the Comfort Flo Humidification System made between October of 2014 and June of 2019. Teleflex Inc. said that all of its Comfort Flo Humidification Systems made after June of 2019 are in good working order. The company replaced its defective components with new columns designed to accommodate high-flow therapies.
The Comfort Flo Humidification System voluntarily recalled by Teleflex Inc. are designed to send a continuous stream of heated and humidified gas to patients. The humidification system uses heated water to humidify the gas breathed in by the patients. Health Care professionals observed a defect when water began infiltrating the system. Water infiltration caused the patients to start aspirating on the water. Aspiration of fluid in the lung and nose areas leads to oxygen desaturation.
Without immediate medical intervention, the patients could have choked and died from the water egress problem. In fact, Teleflex Inc reported that it received several reports of fluid aspiration that led to serious health consequences. Medical professionals resolved the patient aspiration and desaturation problems by commencing invasive breathing support. At least one incident forced medical staff to use a bag-mask ventilation system to save a patient who was aspirating and showed signs of desaturation along with bradycardia.
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